The Federal Circuit decision in Cleveland Clinic Foundation v. True Health Diagnostics LLC, strikes another blow against the patent eligibility of diagnostic methods and highlights the difficulty of enforcing personalized medicine patents. The court affirmed the invalidity of claims related to a blood test for atherosclerotic cardiovascular disease, and agreed with the district court that diagnostic company True Health was not liable for contributory or induced infringement of claims directed to treating patients diagnosed by the blood test. Continue reading this entry
On June 12, 2017, the Supreme Court issued a unanimous decision in Sandoz Inc. v. Amgen Inc. (No. 15-1039), deciding that 42 U.S.C. § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application, and that 42 U.S.C. §262(l)(8)(A) permits a biosimilar applicant to provide 180-days premarketing notice “either before or after receiving FDA approval.” Although the Court left open the possibility that California state law might provide another remedy for Sandoz’s decision not to share its biosimilar application with Amgen and engage in the biosimilar patent dance, it seems unlikely that the Federal Circuit will find both that Sandoz’s decision was “unlawful” and that any additional state law remedies are not preempted by the Biologics Price Competition and Innovation Act (BPCIA).
The Supreme Court could issue its decision in the Amgen v. Sandoz biosimilar patent dance case any day now. Last week I participated in a panel discussion with industry stakeholders considering how the decision might–or might not–impact originator and biosimilar developers.
In Impression Products, Inc. v. Lexmark International, Inc., the Supreme Court reversed the en banc decision of the Federal Circuit, and held U.S. patents rights exhausted by the patent owner’s sale of a patented article anywhere in the world. The Court recognized a patent owner’s ability to impose restrictions through licensing arrangements, but emphasized that patent laws cannot be used against subsequent purchasers. This decision is important for pharmaceutical and biotechnology companies with global operations, especially those who may price their products differently in different countries.
In Mylan Institutional LLC v. Aurobindo Pharma Ltd., the Federal Circuit reviewed a preliminary injunction based in part on a finding of likelihood of success in establishing infringement under the doctrine of equivalents. Although the district court had applied the “function-way-result” test, the Federal Circuit suggested that the “insubstantial differences” test might be more appropriate for chemical cases. Does the court favor that test because it is more likely to lead to a finding of non-infringement?